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Clinical Outcomes, Safety, and Cost-Effectiveness Analysis of Two Catheters (Xianrui Da and Medtronic) in Radiofrequency Ablation for Varicose Veins
Sponsor: Chengdu University of Traditional Chinese Medicine
Summary
This study aims to systematically compare the clinical efficacy (venous closure rate and symptom relief rate), safety (perioperative and postoperative complications), and cost-effectiveness (direct medical costs) of domestic Xianruida radiofrequency catheter and imported Medtronic catheter in endovenous radiofrequency ablation for varicose veins through a single-center, prospective, non-inferiority randomized controlled trial.
Official title: Clinical Outcomes, Safety, and Cost-Effectiveness Analysis of Two Catheters (Xianrui and Medtronic) in Radiofrequency Ablation for Varicose Veins
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-08-01
Completion Date
2026-10-01
Last Updated
2025-07-01
Healthy Volunteers
No
Interventions
Compare the two brands of radiofrequency ablation catheters for the treatment of lower limb varicose veins.
1. Surgical Procedures: Standardized radiofrequency ablation (GSV/SSV closure) was carried out in both groups by the same team. Catheter parameters were set as 120°C and 1 cm/min withdrawal speed. The treatment segment of the great saphenous vein was required to be \>1 cm from the skin before anesthesia. For calf varicose veins, treatment was done after great saphenous vein ablation. * Experimental Group: Utilized Xianruida's catheter with advanced features. Surgical and device - related information was recorded. * Control Group: Used Medtronic's catheter. Similar data were recorded as in the experimental group. 2. Postoperative Management: Consistent for both groups. * Compression: Applied elastic bandage + Class II compression stockings. * Medication: Patients took oral anticoagulants and painkillers as needed, with usage details recorded during follow - up.
Locations (1)
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China